Evaluation of a Strategy Guided by Imaging Versus Systematic Coronary Angiography in Elderly Patients With Ischemia
NCT ID: NCT03289728
Last Updated: 2023-05-30
Study Results
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Basic Information
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UNKNOWN
NA
1756 participants
INTERVENTIONAL
2018-04-04
2024-06-30
Brief Summary
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Indeed, the risk benefit balance of revascularization remains unclear, and complications related to revascularization are more frequent in the elderly, including MI, heart failure, stroke, renal failure and bleeding according to National Cardiovascular Network data.The last randomized controlled trial "After Eighty Study", showed a reduction of major cardio-cerebrovascular events (MACCEs) in NSTEMI patients with an invasive strategy (systematic coronary angiography - CA) compared to a conservative strategy (medical treatment alone). Nevertheless, this study presented several limitations of which a major one was the lack of a definition of frailty at inclusion. Moreover, the "After Eighty Study" has shown that percutaneous revascularization in the invasive arm was only performed for 1 in 2 patients showing an inadequacy in the strategy for selecting candidates for revascularization.
Consequently, despite European Society of Cardiology (ESC) guidelines, the management of NSTEMI in elderly patients is not yet evidence based, and current recommendations do not provide any clear clinical decision rule indicating one strategy over another.
For fragile patients, an alternative strategy consists of selecting candidates for a guided CA according to the extent of myocardial ischemia, identified by non-invasive imaging. Single-photon emission computed tomography or dobutamine stress echocardiograms are currently the reference methods with well-defined interpretation of ischemia. According to our experience, this strategy avoids CA for one third of patients and improves the rate of revascularization.
The aim of our study is to compare 1-year morbidity and mortality in NSTEMI patients over 80 years, assigned to guided versus systematic-CA. Our hypothesis is that the guided strategy will not be inferior on MACE rates at 1 year, and will be cost-effective by reducing iatrogenic complications.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Strategy guided by ischemia imaging
Non-invasive imaging (SPECT or DSE) will be performed. High-risk Patients judged to high risk by imaging (according to ESC guidelines (5)) will undergo coronary angiography aimed at myocardial revascularization and have optimal medical treatment, according to ESC guidelines.
\- Low or intermediate risk patients will receive optimal medical treatment.
Stress single photon emission CT (SPECT) or Stress ultrasound with dobutamine (DSE)
Stress single photon emission CT (SPECT) or Stress ultrasound with dobutamine (DSE), performed using standard protocol.
Patients with ≥ moderate ischemia observed by SPECT (≥ 10% of the myocardium or transient ischaemic dilatation or reduced post-stress ejection fraction (EF)) or abnormal movements of the myocardial walls observed during a stress echocardiogram (≥ 3/17 segments) will benefit from coronary angiography. Depending on the results of coronary angiography and on the coronary anatomy and other clinical and para-clinical considerations (territory of myocardial ischemia) revascularisation will be performed (REVASC). Patients with \< moderate ischemia will receive medical treatment only (MT).
Systematic coronary angioplasty
Patients will routinely undergo invasive coronary angiography aimed at myocardial revascularization.
Cornorary angioplasty
Participants randomized to the SCA group, will benefit from a coronary angiography within 24 to 72 hours after the diagnosis of NSTEMI; without any preliminary ischemia imaging.
Interventions
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Stress single photon emission CT (SPECT) or Stress ultrasound with dobutamine (DSE)
Stress single photon emission CT (SPECT) or Stress ultrasound with dobutamine (DSE), performed using standard protocol.
Patients with ≥ moderate ischemia observed by SPECT (≥ 10% of the myocardium or transient ischaemic dilatation or reduced post-stress ejection fraction (EF)) or abnormal movements of the myocardial walls observed during a stress echocardiogram (≥ 3/17 segments) will benefit from coronary angiography. Depending on the results of coronary angiography and on the coronary anatomy and other clinical and para-clinical considerations (territory of myocardial ischemia) revascularisation will be performed (REVASC). Patients with \< moderate ischemia will receive medical treatment only (MT).
Cornorary angioplasty
Participants randomized to the SCA group, will benefit from a coronary angiography within 24 to 72 hours after the diagnosis of NSTEMI; without any preliminary ischemia imaging.
Eligibility Criteria
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Inclusion Criteria
* Hospitalized for NSTEMI with or without ST-segment depression on electrocardiogram (ECG), and with raised blood concentration of troponin T or I. Raised troponin was defined as a value exceeding the 99th percentile of a normal population at the local laboratory at each participating site. A local cardiologist assessed patient eligibility and clinical condition compatible with a doubt for systematic coronary angiography due to a frailty.
* Written informed consent by the patient or the next of kin in case of incapacity.
* Recurrent or ongoing chest pain refractory to medical treatment
* Haemodynamic instability or cardiogenic shock
* Life-threatening arrhythmias or cardiac arrest
* Contra-indication to CA: Renal failure (creatinine clearance \<15 mL/min by Modification of the Diet in Renal Disease (MDRD)), continuing bleeding problems
* Mechanical complications of MI
* Severe aortic stenosis
* Medical history of severe dementia (documented for more than 3 months)
* Patient under administrative or judicial control
* Patient who are protected under the act
* No health care insurance
80 Years
ALL
No
Sponsors
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University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Gilles Barone-Rochette, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
Locations
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Clinique Mutualiste
Grenoble, , France
University Hospital Grenoble
Grenoble, , France
Countries
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Central Contacts
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Facility Contacts
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GILLES BARONE ROCHETTE, MD PHD
Role: primary
References
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Other Identifiers
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38RC17.012
Identifier Type: -
Identifier Source: org_study_id
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